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Completed

NCT Number: NCT05313178

Changes in Plasma Amino Acid Appearance After Adding Bacillus Coagulans GBI-30, 6086 to Milk Protein Concentrate

The purpose of this study is to examine the pattern of plasma amino acid appearance after a two-week daily regimen of milk protein concentrate supplementation with and without the addition of Bacillus coagulans GBI-30, 6086 among older women.

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Key information

Conditions

Protein Malabsorption

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lindenwood University

Saint Charles, Missouri, 63301, United States

About this study

Once determined eligible and providing consent, participants will be assigned in a randomized, double-blind, crossover fashion to ingest a single daily 25-gram dose of a milk protein concentrate or a similar dose of milk protein concentrate plus bacillus coagulans GBI-30, 6086. Upon arrival for each study visit, participants will have their resting heart rate, blood pressure, body mass, height, and body composition measured. Upon ingestion of their final assigned supplementation dose, standard multiple sample phlebotomy approaches will be used to collect approximately 10mL of venous blood from a forearm vein at specific time intervals up to four hours after ingestion of their final assigned supplementation dose for that period in the study protocol.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All participants will be between the ages of 50-70 years
  • Completing at least 30 minutes of physical activity at minimum three days per week

Exclusion criteria

  • As indicated on a medical history form they complete, any individual who is currently being treated for or diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic, obesity (defined as body mass index > 30 kg/m2), immune, autoimmune, psychiatric, hematological, neurological or endocrinological disorder or disease
  • Any woman who is taking a medication known to impact digestive function or hormonal functions that may impact how our body digests, absorbs, or metabolizes nutrients
  • Any woman currently taking a probiotic or a dietary supplement that may impact digestive function or hormonal functions that may impact how our body digests, absorbs, or metabolizes nutrients
  • Participants who are determined to not be weight stable defined as measured body mass deviating by 2% or more.
  • Participants who do not or are not willing to abstain from alcohol, nicotine, and caffeine for overnight (8-10 hours)
  • Participants who do not or are not willing to abstain from exercise for 24 hours prior to each visit
  • Women who are pregnant
  • Women who are lactose intolerant

Treatment and study plan

Bacillus Coagulans GBI-30, 6086

Dietary Supplement

In a randomized, double-blind, crossover fashion, study participants will supplement on a daily basis for two weeks during one study period with a 25-gram dose of either milk protein concentrate or a 25-gram dose of milk protein concentrate with bacillus coagulans GBI-30, 6086. Each dose will be ingested at the same time of day with 8 - 12 fluid ounces of cold tap water. All participants will be required to complete a supplementation log to document when each dose of their assigned protein is consumed. Upon completion of their first assigned study protocol period, participants will observe a three-week washout period by returning to their normal dietary intake and physical activity habits before beginning supplementation for the remaining study period.

Primary outcomes

  1. Plasma Concentrations of Amino Acids in Blood

    Time frame: 4 hours

    Plasma Concentrations of Amino Acids in Blood

Secondary outcomes

  1. Adverse Events

    Time frame: 4 hours

    Incidence and associations of reported adverse events

Sponsors and collaborators

Lead sponsor

Lindenwood University

Other

Collaborators

  • Increnovo LLC

Registry information

Official study title

Acute Changes in Plasma Amino Acid Appearance After Adding Bacillus Coagulans GBI-30, 6086 to Milk Protein Concentrate in Older Women

Acronym: ABC

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2022
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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